Squaring off against anemia leader Amgen Inc., with help from high-powered partner Celgene Corp., Acceleron Pharma Inc. expects to raise $120 million through the sale of 2.4 million shares at $50 each.
Officials at Acceleron, of Cambridge, Mass., would not talk until after the deal closes next week. But this year promises plenty of data from the company and Summit, N.J.-based Celgene, with the lead compound sotatercept and more.
Sotatercept takes a different approach to anemia than the strong-selling erythropoietin (EPO)-based products and EPO mimetics, such as Thousand Oaks, Calif.-based Amgen’s Epogen (epoetin alfa) for patients on kidney dialysis, and Aranesp (darbepoetin alfa), used in chemotherapy-induced anemia.
An activin receptor Type IIA (ActRIIA) fusion protein, sotatercept binds with activin A and other proteins in the transforming growth factor beta superfamily and inhibits signaling through the ActRIIA receptor.
Acceleron and Celgene reported interim data in December at the American Society of Hematology meeting in New Orleans from a Phase II study that showed dose-dependent increases in hemoglobin in nontransfusion-dependent beta-thalassemia patients on FDA orphan-drug sotatercept.
Within the first two months of receiving the first dose, 84 percent of nontransfusion-dependent patients in each of the 0.5 mg/kg and 0.3 mg/kg dose levels achieved at least a 1 g/dL increase in hemoglobin, while none of the nontransfusion-dependent patients at the lowest dose level made that threshold.
Leerink Swann analyst Marko Kozul wrote in a research report at the time that responses and duration “are likely to improve with continued dose escalation (+0.75 mg/kg), and potential outliers identified through ongoing efforts to prospectively use a biomarker and its correlation.” Kozul raised the trial’s probability of success to an estimate of 40 percent.
More recently, Kozul was looking forward to further data rollouts this year. In the first quarter, data should come forth from a Phase II dose-escalation trial in second-line renal cell cancer, combining sotatercept with Inlyta (axitinib, Pfizer Inc.). In the second quarter, top-line data are likely from the combo trial of sotatercept with ACE-536 (Acceleron’s red blood cell booster, also partnered with Celgene) in myelodysplastic syndromes (MDS) and beta-thalassemia, as well as the first part of a Phase II trial in end-stage renal disease (ESRD).
Last month, Acceleron collected a $7 million milestone payment as a result of the start of the ESRD trial with dialysis patients. The firm is eligible, under the terms of the Celgene deal, to get development, regulatory and commercial milestones of up to $360 million for the sotatercept program.
The fourth quarter is expected to bring full data from the MDS and beta-thalassemia trials, and maybe Phase II results from the combo experiment of Acceleron’s other candidate, dalantercept (an anti-angiogenesis therapy not included in the Celgene deal) with Nexavar (sorafenib, Bayer AG and Amgen) in hepatocellular carcinoma.
In a research report earlier this month, Kozul added “heavily risk-adjusted revenue potential in ESRD patient subsets to our model,” and kept his “outperform” rating while upping the price target from $35 to $52. Acceleron shares (NASDAQ:XLRN) closed Thursday at $51.01, down $5.69, or 10 percent.
The company went public in September, generating almost $84 million – above its $75 million target – from the sale of 5.58 million shares of common stock at $15 per share, which was at the high end of the firm’s stated $13 to $15 price range. Acceleron got $10 million more from a concurrent private placement made by Celgene. The firms began their deal in 2008 and extended it in 2011. (See BioWorld Today, Aug. 8, 2013, and Sept. 20, 2013.)
Citigroup and Leerink Partners LLC are acting as joint book-running managers for the latest Acceleron offering, with Piper Jaffray & Co. as lead manager and JMP Securities as co-manager.
In other financing news:
Biozone Pharmaceuticals Inc., of Bothell, Wash., raised about $2.7 million from eight accredited investors including Opko Health Inc., of Miami. The private placement offering included the sale of 5.5 million shares of restricted common stock and 5.5 million 10-year warrants exercisable at 50 cents per share. Proceeds from the financing will be used for research and development, as well as general working capital.
Celladon Corp., of San Diego, filed an amended prospectus for its initial public offering (IPO). The company had intended to sell 5 million shares at $14 to $16 per share, and postponed the IPO in November 2013. The company’s updated filing removed the original terms. Celladon plans to list on Nasdaq under the symbol “CLDN.” Barclays is the sole bookrunner on the deal. (See BioWorld Today, Oct. 14, 2013, and Nov. 15, 2013.)
Egalet Ltd., of Malvern, Pa., plans to raise $42 million by offering 3.5 million shares at a price range of $11 to $13 in an initial public offering. The company intends to trade on Nasdaq under the symbol “EGLT.” Stifel and JMP Securities are the joint bookrunners on the deal.
Emergent Biosolutions Inc., of Rockville, Md., said it intends to offer, subject to market and other conditions, $200 million worth of convertible senior notes due 2021 in a private placement to qualified institutional buyers. The company will grant the initial purchasers an option to purchase up to $30 million more in notes. Emergent intends to use a majority of the net proceeds from the offering to finance the acquisition of Cangene Corp., of Winnipeg, Manitoba, disclosed late last year. Shares of Emergent (NYSE:EBS) fell $2.86, or 10.8 percent, to close Thursday at $23.55.(See BioWorld Today, Dec. 13, 2013.)
Exelixis Inc., of South San Francisco, priced an overnight, underwritten public offering of 10 million shares at $8 each, granting underwriter Cowen and Co. a 30-day option to buy as many as 1.5 million more shares. Exelixis anticipated that net proceeds from the offering will be $75.6 million after the underwriting discount. The company expects to use the proceeds for general corporate purposes.
Five Prime Therapeutics Inc., of South San Francisco, filed a prospectus to raise up to $50 million through a stock sale. The number of shares and price per share were not specified. Jefferies, BMO Capital Markets and Wells Fargo Securities were listed as joint bookrunners for the deal, with Guggenheim Securities as co-manager.
Genocea Biosciences Inc., of Cambridge, Mass., set the terms for its initial public offering, intending to sell 5.5 million shares at a range between $12 and $14 each. (See BioWorld Today, Dec. 26, 3013.)
Keryx Biopharmaceuticals Inc., of New York, priced an underwritten public offering of common stock consisting of 6.9 million shares at $14.50 per share, for about $100 million. Keryx granted to the underwriters a 30-day option to purchase more shares, equal to as much as 15 percent of the number of shares of stock sold in the offering. Keryx intends to use the net proceeds from the sale of its common stock to fund pre-launch/launch inventory buildup and pre-commercial/commercial activities related to Zerenex (ferric citrate), the ongoing development of Zerenex in pre-dialysis and other general corporate purposes. J.P. Morgan Securities LLC is acting as sole book-running manager in the offering. Shares of Keryx (NASDAQ:KERX) closed Thursday at $15.45, up 85 cents.
Protalex Inc., of Florham Park, N.J., completed a private placement financing to accredited investors of 471,334 shares of its common stock at $6 per share, yielding gross proceeds of about $2.8 million. No commissions were payable in connection with the financing transaction. Proceeds will be used for working capital purposes, principally to fund ongoing clinical trials and studies and related activities. The investors in the offering were granted piggy-back registration rights in connection with certain registration statements filed by the company, subject to certain exceptions, including a registration statement filed in connection with a primary offering by the company, Protalex said.